A Biological Atlas of Severe Obesity (Biological Tissue Collection) (ABOS)

• ClinicalTrials.gov Identifier: NCT01129297
• Recruitment Status: Recruiting
• First Posted: May 24, 2010
• Last Update Posted: May 24, 2022
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Study Description

Brief Summary:

Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood.

We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.

Condition or disease
Obesity; Glucose Intolerance; Diabetes

Detailed Description:

Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism "diabesity".

This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.

Study Design

• Study Type: Observational
• Estimated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)
• Actual Study Start Date: June 13, 2006
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: January 2025

Groups and Cohorts

Group/Cohort
BMI ≥ 35 kg/m2 and diabetes; BMI (Body Mass Index) ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
BMI ≥ 35 kg/m2 with intolerance glucose; BMI (Body Mass Index) ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose> 6 mmol/L and <7 mmol/l and / or> 7.8 mmol/l and <11.1 mmol/l , 120 minutes after ingestion of glucose (oral glucose tolerance test)
BMI ≥ 35 kg/m2 without diabetes; BMI (Body Mass Index)≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
BMI <27 kg/m2 without diabetes; BMI (Body Mass Index) <27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
27 < BMI < 35 kg/m2 without diabetes; BMI (Body Mass Index) <27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)

Outcome Measures

Primary Outcome Measures :

1. Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism [ Time Frame: Baseline ]
   Study the correlation between the glycemic status (fasting glucose and / or after ingestion of glucose) adjusted to the presence or absence of obesity (Body Mass Index) and gene expression in tissues involved in glucose metabolism before bariatric surgery

Secondary Outcome Measures :

1. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [ Time Frame: 1 year ]
   Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
2. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [ Time Frame: 2 years ]
   Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
3. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) [ Time Frame: 5 years ]
   Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
4. Prospective assessment of clinical and biological features before and after bariatric surgery [ Time Frame: 1 year ]
   Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose, fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
5. Prospective assessment of clinical and biological features before and after bariatric surgery [ Time Frame: 2 years ]
   Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
6. Prospective assessment of clinical ans biological features before and after bariatric surgery [ Time Frame: 5 years ]
   Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
7. Genotype-Phenotype correlation [ Time Frame: Baseline ]
   Genotype-Phenotype correlation based on medical and family history

Biospecimen Retention:   Samples With DNA

• Liver samples before and at 1 and 5 years after bariatric surgery
• Muscle samples before and at 1 year after bariatric surgery
• Subcutaneous fat samples before and at 3 month and 1 year after bariatric surgery
• Visceral fat samples in the great omentum before bariatric surgery
• Intestinal samples during gastric by-pass surgery
• Blood samples

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Recruiting: Clinical Medical Center from the north of France

Criteria

Inclusion Criteria:

• Age between 18 and 65 years
• Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical

• Phenotype corresponding to one of the following four cases :

  1. Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  2. Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose> 6 mmol/L and <7 mmol/l and/or> 7.8 mmol/l and <11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  3. Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
  4. Body Mass Index <27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)

5)27 <Body Mass Index <35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)

Exclusion Criteria:

• unable to receive clear information
• refusal to sign the consent form
• pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue

Contacts and Locations

Contacts

Contact: Francois PATTOU, MD PhD; fpattou@univ-lille2.fr

Contact: Violeta Raverdy, MD; vraverdi@univ-lille2.fr

Locations

France

Lille University Hospital; Recruiting

Lille, Nord, France

Contact: François PATTOU, MD, PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

• Principal Investigator: Francois PATTOU, MD PhD; Lille University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.1186/s12920-019-0536-1.

Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT01129297
• Other Study ID Numbers: 2006_0620; DGS 2006/0307 ( Other Identifier: AFSSAPS )
• First Posted: May 24, 2010
• Last Update Posted: May 24, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:

Obesity; surgery; genetic expression; collection of samples

Additional relevant MeSH terms:

Obesity; Glucose Intolerance; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases